Benvenue Medical Receives CE Mark Approval for Kiva VCF Treatment System

Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, announced today that it has received CE Mark approval in Europe for the Kiva™ Vertebral Compression Fracture (VCF) Treatment System. Initial clinical cases in Europe using the Kiva System have been successfully performed and the company is preparing for the commercial launch of the product throughout the region.

The Kiva System addresses unmet needs of spine physicians who treat painful VCFs due to osteoporosis, trauma, and cancer. The Kiva System incorporates Benvenue Medical’s proprietary, flexible spinal implant technology. The implant, which is manufactured from PEEK, is introduced using a percutaneous, over-the-wire technique. It reduces and stabilizes the fracture and is designed to provide containment during delivery of PMMA bone cement.

In over one year of clinical use, the Kiva System has provided VCF patients with immediate pain relief and consistent functional improvement, while requiring significantly less bone cement than is customarily used in kyphoplasty and vertebroplasty procedures.

The first clinical cases in Europe using the Kiva System were recently performed by Dr. Stephan Becker at the Orthopedic Hospital Speising in Vienna, Austria.

“Among all of the new approaches to VCF repair that I have seen, the Kiva System offers a new unipedicular method to improve the treatment of these painful fractures,” said Dr. Becker. “The system deploys an implant that can restore height and provide a safe containment for low viscosity cement.”

VCF treatment represented a global market of approximately $600 million and over 200,000 procedures in 2008. The market remains underpenetrated, with roughly 700,000 additional VCF patients diagnosed each year worldwide. The fast growing European VCF market currently represents about 25% of the global market.

“The CE Mark is an important milestone for the company because it allows us to commercialize the Kiva System in some of the largest and fastest growing VCF markets in the world, and further validate the benefits delivered by the system through expanded clinical use,” said Laurent Schaller, president and CEO of Benvenue Medical.

Mr. Schaller will provide additional information regarding the Kiva System, and an update regarding the company’s progress in the field of minimally invasive spinal fusion, at the Canaccord Adams Musculoskeletal Conference in Las Vegas on Tuesday, February 24, 2009.

Source: Benvenue Medical

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